NCT01701726

Effect of Acupuncture on Patients With Mild Hypertension

Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Detailed description

Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(WL, n=107)will not be given any intervention.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
OTHER	acupuncture	In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.
OTHER	Sham acupuncture	In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2012-10-05
• Last updated: 2016-06-21

Locations

1 site across 1 country: China